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Pharmacist Speaks Out as Patient on Compounding Legislation

May 09, 2014
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Rep. Cathy McMorris Rodgers (R-Wash.) speaks with Michael Brandt about his experiences with an NECC-compounded medication.

WHEN MICHAEL L. BRANDT, PHARM.D., FASHP, heard reports last fall of contaminated injectable steroids prepared by the now defunct New England Compounding Center (NECC) in Framingham, Mass., he resolved not to panic.

He had been receiving injections of compounded methylprednisolone acetate (MPA) for nearly 18 months for pain from an unstable vertebra in his back, and he knew there was a chance that at least one of his injections came from lots linked to an outbreak of meningitis, so the first thing he did was investigate the origin of the shots he had received.

An Uncertain Risk Outlook

Initially, he met with good news:  His shots did not come from the lots authorities declared contaminated. But as the story of NECC unfolded, it soon became apparent to Brandt that lot numbers were nearly irrelevant.

“This wasn’t just a speck of dirt on a picture frame. The conditions were so deplorable, it was painfully obvious that they had existed for a long time,” said Brandt, clinical pharmacy supervisor at Kootenai Health, Coeur d’Alene, Idaho. “That raises the possibility that the lot I received was contaminated.” Indeed, when authorities inspected the facility, they found rust, mold, and filthy ventilation, all of which resulted in contaminating injections that have thus far killed 64 people and sickened another 686 more, many of them senior citizens.

The Centers for Disease Control have been tracking the number of patients who have fungal infections linked to the NECC steroid injections.

The Centers for Disease Control has been tracking the number of patients who contracted fungal infections from NECC steroid injections.

According to the U.S. Centers for Disease Control and Prevention (CDC), after the recall of NECC steroid medications last September, state and local health departments  identified approximately 14,000 people in 23 states who were potentially exposed to contaminated MPA, of which 11,000 received spinal or paraspinal injections.

Across the nation, patients who received MPA injections prepared by NECC in that timeframe are still being diagnosed with fungal infections. Thus far, the CDC has been unable to determine whether the infections take several months to incubate or whether patients are not diagnosed until the infections are several months along. For now, those who have received potentially contaminated injections have been informed of their risk.

Brandt says that he will relay the information to his care providers whenever necessary. “It will always be at the back of my mind. If I get headaches or other symptoms, [having received these shots] is something to put into the differential diagnosis.”

Keep Calm and Advocate

There are no tests to determine whether a fungus has taken up residence in the spinal fluid, but Brandt is determined not to let the uncertainty ruin his life.

“When I found out, I thought, ‘Okay, I’m not sick and I’m not immunocompromised, so my risk is probably lower than other people’s,’ ” he said. “But I know there’s a possibility that the fungus may be there and may one day make me sick or kill me. I just don’t want to waste a lot of personal energy worrying about something that may or may not happen.”

Instead, Brandt is channeling his energies into holding both the profession and the government to the highest of standards. “I’m disappointed in those [NECC] professionals who call themselves pharmacists who worked in and allowed those conditions. I would never sign off on that. I would quit first.”

I know there’s a possibility that the fungus may be there and may one day make me sick or kill me.

Although he acknowledges that most compounding pharmacies do a good job, Brandt points to NECC as evidence that a lack of government oversight leaves too much room for potentially lethal short-cuts.

“Why would [NECC] think that this is okay? Obviously, it’s greed. Doing the right thing is not cheap,” he said, noting the expense of the steps, materials, and labor required to maintain clean rooms and a sterile environment.

A Regulatory Gray Area

Brandt believes that the NECC case exemplifies how compounding pharmacies operate in a regulatory gray area with respect to how they prepare, market, and sell their products.

From left, Rachelle Albay, a Pharm.D. student at Washington State University College of Pharmacy at the time of this picture, and Michael Brandt pose in front of the Capitol Building.

“When going through pharmacy school, I learned that there was a big difference between manufacturing and compounding. Compounding was something specific to one individual. Manufacturing means making a large batch of sterile products that you sell to providers,” he said, questioning how NECC could have such a large operation that it could produce and sell so many injections in such a short period of time.

In September, Brandt flew to Washington, D.C., to talk to his senators and representative in favor of Senate Bill 959, the Pharmacy Quality Security and Accountability Act. This legislation was designed to create a new category of producer called “compounding manufacturer” that must register with and be inspected by the Food and Drug Administration.  He considers such cross-country endeavors to be a key part of the way he delivers care and advocates for patients, and it’s something he would have done even if he had not had to grapple with the NECC debacle on a personal level.

“We in the medical community need to do the right thing for the patient,” Brandt said. “Sometimes, factors such as regulation and lack of resources get in the way. Sometimes, the focus becomes a bit jumbled, but patient care should always be the top priority. I have a very strong moral guidance that way.”

A Step in the Right Direction

In October 2013, S. 959 was replaced with a less stringent bill in the House of Representatives, HR 3204, The Drug Quality and Security Act, which President Obama signed into law in November. The new law clarifies the Food and Drug Administration’s authority over compounded medications, establishes a new class of compounding manufacturer known as an “outsourcing” facility, and creates a national set of standards for tracking pharmaceuticals through the supply chain.

The new legislation, while not providing for tight oversight the way S. 959 would have, is a step in the right direction, said Brandt.

“It’s not exactly what we wanted, but it’s something. We got what we needed, and through ASHP and legislative activities, we raised awareness of the issue. I’d like to believe that even this may not have passed had we not gone through the efforts of lobbying,” he said.

Some sectors have criticized the new law, saying it fosters government encroachment on business, but Brandt dismisses such criticism out of hand. “Everyone else—health systems, hospitals, manufacturers—is regulated, so this fits into what government should be doing. We have a case where the compounding industry has not self-regulated and has not done due diligence, so now it’s necessary for the government to step in. The government didn’t ask for this. The industry failed.”

Government oversight is a matter of public safety, Brandt said. “It’s outbreaks like this one that we want to prevent. There are so many compounding pharmacies, and so many people who depend on their medications to be sterile and not dangerous. If these problems can be avoided by oversight, why would you risk them? It’s a no-brainer.”

 

—By Terri D’Arrigo

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